Preoperative percutaneous or transvascular marking for curative resection of small liver tumours with potential for missing during hepatectomy: a study protocol for an open-label, single-arm phase II study
Hiroshi Sakai,
Masataka Tsuge,
Masahiro Ohira,
Tsuyoshi Kobayashi,
Ryosuke Nakano,
Shintaro Kuroda,
Hiroyuki Tahara,
Hideki Ohdan,
Ko Oshita,
Yosuke Namba,
Sotaro Fukuhara,
Keiso Matsubara,
Daisuke Takei,
Tomokazu Kawaoka,
Naruhiko Honmyo,
Keigo Chosa,
Kazuo Awai
Affiliations
Hiroshi Sakai
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Masataka Tsuge
Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan
Masahiro Ohira
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Tsuyoshi Kobayashi
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Ryosuke Nakano
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Shintaro Kuroda
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Hiroyuki Tahara
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Hideki Ohdan
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Ko Oshita
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Yosuke Namba
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Sotaro Fukuhara
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Keiso Matsubara
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Daisuke Takei
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Tomokazu Kawaoka
Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan
Naruhiko Honmyo
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
Keigo Chosa
Diagnostic Radiology, Hiroshima University, Hiroshima, Japan
Kazuo Awai
Diagnostic Radiology, Hiroshima University, Hiroshima, Japan
Introduction Small liver tumours are difficult to identify during hepatectomy, which prevents curative tumour excision. Preoperative marking is a standard practice for small, deep-seated tumours in other solid organs; however, its effectiveness for liver tumours has not been validated. The objective of this study is to evaluate the effectiveness of preoperative markings for curative resection of small liver tumours.Methods and analysis This is an open-label, single-arm, single-centre, phase II study. Patients with liver tumours of ≤15 mm requiring hepatectomy will be enrolled and will undergo preoperative marking by placing a microcoil near the tumour using either the percutaneous or transvascular approach. The tumours, including the indwelling markers, will be excised. The primary endpoint will be the successful resection rate of liver tumours, defined as achieving a surgical margin of ≥5 mm and ≤15 mm. Secondary endpoints will include the results of preoperative marking and hepatectomy.Ethics and dissemination Ethical approval for this trial was obtained from the Ethical Committee for Clinical Research of Hiroshima University, Japan. The results will be published at an academic conference or by submitting a paper to a peer-reviewed journal.Trial registration number jRCTs062220088.
